CinnaGen History
CinnaGen Co. was founded in 1994 with the goal of manufacturing hi-tech products in biotechnology and related fields. Since its start of operation with 4 scientists, CinnaGen has grown to become the biggest bio-pharmaceutical manufacturer and biotech exporter in the region. The concept was to be active in the research and development of new potent biotech-based products to cover regional markets. Enzymes, molecular biology reagents and PCR kits were the first products and then CinnaGen used its proprietary set of technologies to endow monoclonal antibodies for blood group typing. The next important step for CinnaGen was to enter therapeutic recombinant proteins and monoclonal antibodies area.
Today the company prides itself in its innovative skills meeting today challenges. We focus our efforts on developing the biosimilar candidates in the areas of Immunological diseases, MS, Infertility, Diabetes, Kidney diseases, Osteoporosis, Hormone disorders and Oncology as well as providing contract research development services. The company is spending over 20 percent of its total turnover on R&D activities.
CinnaGen is strategically positioned to become and remain a leading biotechnology company in the region. Our aim is to use our expertise to identify and acquire selected products through strategic partnerships to promote sustainable development in human health.
1994: Estabilishment of the CinnaGen
CinnaGen Co. was established in 1994 by a group of young Iranian scientists.
1995: Production and Marketing of Taq DNA polymerase
CinnaGen Co. is the 1st Iranian Taq DNA polymerase manufacturer in the MENA region.
1997: Production and Marketing of Molecular Diagnostic kits(PCR-based technology)
1999: Production of ABO grouping kit-entering the area of diagnostic monoclonal antibodies production
CinnaGen is the 1st Monoclonal Antibody producer in MENA region.
2000: Pharmaceutical Synthetic Peptides Production
Production of GnRH-entering the area of pharmaceutical synthetic peptides production
2000: ISO Granted
ISO 9001:1994 Granted
2002: New Biotechnology Services
Primer synthesis service
DNA sequencing service
Production of Restriction enzymes
2004: Construct SD1
Inauguration of manufacturing-plant in Simindasht-Karaj (record breaking construction in 10 months)
Production of Busereline-Acetate
2005: First Recombinant Drug, Now in Market
Launching CinnoVex in the local market as the second producer in the world after Biogen-Idec
GMP Certificate granted by MOH of I.R.Iran
2006: CinnoVex Launch
CinnaGen get release license of CinnoVex (interferon Beta- 1a) from Iranian FDO.
2008: Powering up
Starting Clinical Trial of Betapoietin and ReciGen(rec Hu-IFN beta 1a-44 microgram)
Cooperation with Dr. Reddy-India for Technology transfer of Rituximab
rec Hu-FSH in the pipeline rec Hu-PTH in the pipeline
ISO 13485:2003 and 9001:2008 Granted
2008: High Dose Achieved
Launching ReciGen(rec Hu-IFN beta 1a-44microgerams)
Production of Reditux™(Rituximab) therapeutic monoclonal antibody
Rec Hu-PEG-GCSF in the pipeline
2009: ReciGen Launch
CinnaGen got release license of ReiGen (interferon Beta- 1a) from Iranian FDO.
2010: Beyond the Boundaries
Registration of CinnoVex™ in Russia, Syria and Armenia
Launching Betapoietin (rec Hu-EPO beta)
Starting Clinical Trial of CinnoPar (rec Hu-PTH)
2011: New Building
Commencing the construction of a new production facility SD2.
Launching Reditux™ (Rituximab)as the first Monoclonal antibody produced in Iran
Launching CinnaFact (Buserelin Acetate)
2011: CinnaFact Launch
CinnaGen got release license of CinnaFact (Buserelin) from Iranian FDO.
2012: GMP based on EMA Regulations
Commencing the construction of a new warehouse facility SD3 (Simin dasht-3)
Qualification and running of new state of the art GMP facility (SD-2) based on EMA Regulations.
Registration of ReciGen® in Syria
Registration of CinnoVex™ in Azerbaijan
2013: Expanding our basket
Launching Cinnal f® (Follitropin alfa)as the first follitropin biosimilar produced in Iran
Launching CinnoPar® (Teriparatide) as the first parathyroid hormone (1-34) biosimilar produced in Iran
Launching CinnaPoietin® (rec Hu-EPO beta)
Launching PegaGen® (Peg-filgrastim) as the first Pegylated filgrastim biosimilar produced in Iran
Launching Recigen in Syria
2013: CinnoPar Launch
CinnaGen got release license of CinnoPar (Parathyroid Hormone) from Iranian FDO.
2013: Cinnal-f Launch
CinnaGen got release license of Cinnal-f (Follitropin alfa) from Iranian FDO.
2014: PegaGen Launch
CinnaGen got release license of PegaGen (Pegylated Filgrastim) from Iranian FDO.
2014: CinnaPoietin Launch
CinnaGen got release license of CinnaPoietin (Erythropoietin) from Iranian FDO.
2015: CinnoMer Launch
CinnaGen got release license of CinnoMer (Glatiramer) from Iranian FDO.
2015: CinnoTec Launch
CinnaGen got release license of CinnoTec (Dimethyl Fumarate) from Iranian FDO.
2016: CinnoRA Launch
CinnaGen got release license of CinnoRA(Adalimumab)from Iranian FDO
2016: Facility and Capacity Expansion
opening of SD-4 with capacity expansion to 13000 liters Bioreactor, First GMP Approved cartridge filling and pen assembly line in IRAN.
2016: New Era in quality
Outlook of EU registration in 2020: starting phase I clinical trial in Europe for CinnoVex
2016: Estabilishment of the CinnaGen İlaç
CinnaGen Pharmaceutical Group established a new company in Turkey in name of CinnaGen ilaç
2017: CinnaTropin Launch
CinnaGen got release license of CinnaTropin(Somatropin) From Iranian FDA.
2017: New Treatment, New Hope
Starting clinical trials for new biosimilars; Pertuzumab, Cetuximab, Eculizumab, pegylated Interferon beta, Liraglutide
2017: KidiPeg Launch
CinnaGen got release license of KidiPeg (Pegylated Filgrastim) From Iranian FDA.
2017: New Building
Staring construction of new facility in Çerkezköy in the Marmara Region of Turkey.
2017: New Building
Staring construction of new facility, SD-5
2018: Eu GMP Certification
CinnaGen obtain GMP certification from the European Union.
2019: CinnaGen ilac has been established in 2019
This company is the first full cycle manufacturing site to produce biosimilars in Turkey.
2019: Facility and Capacity Expansion
Opening of SD-5 Facility and Capacity Expansion with EU GMP Approved
Mission Statement
Mission
Faith in self-confidence of young and skilled personnel in CinnaGen encouraged us to enter international pharmaceutical markets in the hope of creating a more radiant and healthier tomorrow for the future of mankind. In striding the way, every day we continuously pursue the enlightening terms of quality and safety and pride ourselves on moving in line with the world’s latest scientific and research developments.
Vision
Our ideal is to top an exalted position in quality and be recognized as a pioneer, innovative, eminent and value creative company for patients, customers, personnel,business partners, investors and the world community in which we live.
Values
CinnaGen values about Innovation, honesty, studiousness and steady persistence and highest compliance with business conducts and ethics. Also applying the latest world technology in doing research, production and presentation of products and valued service, Creating mutual trust among patients, customers, staff, shareholders and community, Safeguarding properties and fixed and intangible assets of the company and the others, Constant training and skill improvement of all the beneficiaries of the organization, Compliance with the latest standards and national and international regulations,Promoting and encouraging teamwork and individual efforts, Principle and care at the best possible level, Using promotions that are based on competency and Protection of the clean environment.
Quality Control
At CinnaGen’s quality control lab we perform accurate and timely testing of various samples(raw material, inprocess, drug substance, drug product and stability samples) with modern and uptodate equipment and state of the art cGMP compliant methods, to make sure that quality, safety and efficacy of our products meet the highest level possible. Our internal auditor constantly try to keep everything under control with the best quality possible . We give our best effeort to our work and we put our patients first.
Quality Assurance
Our quality activities in Quality Assurance is including all of MANUFACTURING processes which start from the time of receiving raw material and continue until final product which is used by the end user in order to assure of achieving required results. Quality Assurance Dept. of CinnaGen has the responsibility for documentation, Validation, Audit and inspection and batch release and carries out the duties according to the latest PIC/S, ICH and WHO guidelines. CinnaGen was granted ISO 9001 certificate in Quality Management System (in 2000), ISO 13485 in medical devices quality management (in 2005) and INFDQA (Iranian National Food and Drug and Health Quality Award in 2010). During all these years CinnaGen has kept these certificates and also is granted another valuable certificates including ISO 14001, ISO 18001, ISO 10002 and ISO 10015.